The Biostatistical Technical Guidelines for Clinical Trials of Chemical Pharmaceuticals and Biologics was issued on Mar. 18, 2005. It gives biostatistical technical guidelines for clinical trials of chemical pharmaceuticals and biologics in China, which includes:

1. Overview

2. Basic Considerations for the Entire Clinical Trial

3. Basic Considerations in Experimental Design

4. Basic Considerations in Conducting Trials

5. Data Management

6. Statistical Analysis

7. Statistical Analysis Report

8. Glossary

9. References

10. Appendix